Breast Cancer Clinical Trial
Official title:
Outcome of Neo-adjuvant Chemotherapy Followed by Breast Conservative Surgery in Breast Cancer in Upper Egypt
Systemic chemotherapy along with radiotherapy has been successfully used to post-operatively
manage patients following tumour resection in breast cancer.
This was further supported with clinical trials conducted in the 1970s and 1980s which shows
significant improvement in progression-free of tumours and overall survival rates in patients
who undergo chemotherapy for operable breast cancer.(1)-(2) Neoadjuvant chemotherapy on the
other hand, involves the administration of the chemotherapeutic agents some weeks before
appropriate breast surgery. This induces reduction in the tumour size and allows for breast
conservative surgery instead of mastectomy in some cases.
Techniques for tumour localization in neoadjuvant chemotherapy using metallic markers
allowing lower excision of breast tissue without compromising margins and breast conservation
being feasible in many patients have evolved over time.(3)-(7)-(9) However, there are recent
concerns questioning the increase use of neoadjuvant chemotherapy in breast cancer it as it
may not be beneficial to patients in the long run.(10)
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | December 2020 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 69 Years |
Eligibility |
Inclusion Criteria:1- female patients diagnosed with breast cancer and are attending
oncology or surgical unit of Assiut university hospital . 2- breast cancer will be diagnosed by core-needle biopsy. 3- all patients must have complete history and physical examination (including careful assessment of breast and axillary lymph nodes). 4- All patients must have routine laboratory tests (CBC, liver and renal function tests, and alkaline phosphatase) and radiological tests (chest x-ray, pelvic-abdominal ultrasound, bilateral mammography with confirmatory ultrasound and complete echocardiography to assess the cardiac function). 5- written consent from patients. Exclusion Criteria: - 1- Elderly patients more than 70years old. 2- Previous treatment for breast cancer. 3- Presence of co-existing malignancies. 4- Pregnancy or lactation at time of diagnosis. 5- Severe renal, hepatic or haematological abnormalities. 6- Bilateral breast cancer. 7- advanced breast cancer |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University Hospital | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Abdel-Bary N, El-Kased A, Aiad H. Does neoadjuvant chemotherapy increase breast conservation in operable breast cancer: an Egyptian experience. Ecancermedicalscience. 2009;3:104. doi: 10.3332/ecancer.2008.104. Epub 2009 Apr 9. — View Citation
Bobin JY, Al-Khaledi K, Ahmad J. Breast conservative surgery for operable invasive ductal carcinoma after neoadjuvant chemotherapy or hormonal therapy- a challenge for breast surgeon: a review based on literature and experience. Gulf J Oncolog. 2011 Jan;(9):45-51. Review. — View Citation
Espinosa-Bravo M, Sao Avilés A, Esgueva A, Córdoba O, Rodriguez J, Cortadellas T, Mendoza C, Salvador R, Xercavins J, Rubio IT. Breast conservative surgery after neoadjuvant chemotherapy in breast cancer patients: comparison of two tumor localization methods. Eur J Surg Oncol. 2011 Dec;37(12):1038-43. doi: 10.1016/j.ejso.2011.08.136. Epub 2011 Sep 21. — View Citation
Inaji H, Komoike Y, Motomura K, Kasugai T, Sawai Y, Koizumi M, Nose T, Koyama H. Breast-conserving treatment after neoadjuvant chemotherapy in large breast cancer. Breast Cancer. 2002;9(1):20-5. Review. — View Citation
Kuerer HM, Singletary SE, Buzdar AU, Ames FC, Valero V, Buchholz TA, Ross MI, Pusztai L, Hortobagyi GN, Hunt KK. Surgical conservation planning after neoadjuvant chemotherapy for stage II and operable stage III breast carcinoma. Am J Surg. 2001 Dec;182(6):601-8. — View Citation
Schwartz GF, Meltzer AJ, Lucarelli EA, Cantor JP, Curcillo PG 2nd. Breast conservation after neoadjuvant chemotherapy for stage II carcinoma of the breast. J Am Coll Surg. 2005 Sep;201(3):327-34. — View Citation
Vaidya JS, Massarut S, Vaidya HJ, Alexander EC, Richards T, Caris JA, Sirohi B, Tobias JS. Rethinking neoadjuvant chemotherapy for breast cancer. BMJ. 2018 Jan 11;360:j5913. doi: 10.1136/bmj.j5913. — View Citation
Van Praagh I, Cure H, Leduc B, Charrier S, Le Bouedec G, Achard JL, Ferriere JP, Feillel V, De Latour M, Dauplat J, Chollet P. Efficacy of a primary chemotherapy regimen combining vinorelbine, epirubicin, and methotrexate (VEM) as neoadjuvant treatment in 89 patients with operable breast cancer. Oncologist. 2002;7(5):418-23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumour size measurement | Measurement of tumuor size before and after six courses of FEC-100 | 18 WEEKS |
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